Regulatory Focus™ > News Articles > Regulatory Reconnaissance (18 November 2013)

Regulatory Reconnaissance (18 November 2013)

Posted 18 November 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • WSJ's Must-Read Series on Patients Helping to Bring Rare Disease Therapies to Market (WSJ)
  • Track and Trace, Compounding Bill set for Passage Today (RxTrace)
  • Did FDA Just Appoint an Anti-Vaxxer to its Vaccines and Related Biological Products Advisory Committee? (Skewed Distribution) (FDA)
  • Emergency meningitis vaccine will be imported to halt Ivy League outbreak (NBC) (NYTimes) (Bloomberg) (NPR)
  • Simulators Help Build a Better Drug Trial (WSJ-$)
  • Sequester threatens FDASIA success, Woodcock says (SCRIP-$)
  • Shuren To Lawmakers: Sequestration Is "Killing Us" (Gray Sheet-$)

In Focus: International

  • French court rules TÜV liable in PIP breast implants trial (DW) (EP Vantage)
  • MHRA: Epilepsy Drugs Should not be Substituted (Financial Times-$)
  • Health Canada to Increase Transparency Around Medical Device Trials (Health Canada)
  • German Pharma Balks As Second HTA Retrospective Assessment Includes Orphan Drugs (Pink Sheet-$)
  • EMA encourages companies to submit quality type-I variations for 2013 by end of November (EMA)
  • Japanese team tightening Ranbaxy unit operations (Business Standard)
  • Indian Govt to change D&C Rules on labeling norms, shelf life of medical devices (PharmaBiz)

US: Pharmaceuticals/Biotechnology

  • WSJ's Must-Read Series on Bringing Rare Disease Therapies to Market (WSJ)
  • Track and Trace, Compounding Bill set for Passage Today (RxTrace)
  • Did FDA Just Appoint an Anti-Vaxxer to its Vaccines and Related Biological Products Advisory Committee? (Skewed Distribution) (FDA)
  • Emergency meningitis vaccine will be imported to halt Ivy League outbreak (NBC) (NYTimes) (Bloomberg) (NPR)
  • FDA wants new controls to help prevent outbreaks of drug-resistant bacteria (The Hill)
  • BioMarin's rare disease drug gets so-so FDA review (Fierce) (SCRIP-$) (Market Watch) (BioCentury) (Pink Sheet-$)
  • Simulators Help Build a Better Drug Trial (WSJ-$)
  • FDA 'frustrated' by sunscreen delay (The Hill)
  • Sequester threatens FDASIA success, Woodcock says (SCRIP-$)
  • New Design Coming for FDA's Website? See this Recall Notice: (FDA)
  • FDA Uses Biosimilar Strategy For Complex Generics, Offers Pre-ANDA Meetings (Pink Sheet-$)
  • ANDA Sponsors May Receive Early Notification Of Upcoming Actions, Woodcock Says (Pink Sheet-$)
  • Following talks with FDA, Sanofi drops fedratinib development (Pharma Letter-$) (SCRIP-$) (Reuters) (PMLive) (Fierce) (Pharma Times)
  • In Demand in Clinics and on the Street, Suboxone can Be a Savior or a Menace (NYTimes)
  • First Amendment Challenge Mulled As Amarin Seeks To Unchain ANCHOR Results (Pink Sheet-$)
  • Chicago Subpoenas J&J Over 'Deceptive' Opioid Marketing (Pharmalot)
  • "Biobetters" startup based on drug discovery tech from Scripps lands $9 million (MedCity News)
  • Drugmakers confront new pay-for-delay cases under new rules (Fierce)
  • Onconova could file NDA for cancer drug rigosertib next year (Pharma Letter-$)
  • SCOTUS Chief Justice denies Teva request (BioCentury)
  • Paion's "safe anesthetic" remimazolam performs in Ono's PhII/III study (SCRIP-$)
  • The Burzynski Empire strikes back (Science-Based Medicine)
  • Culture Change in Industry Necessary for Success Under GDUFA (Lachman)
  • FDA approves one-week anti-fungal drug made by Valeant (DSN) (Press) (DD&D)
  • Recall Ordered by Compounding Pharmacy due to Sterility Issues (FDA)

US: Pharmaceuticals and Biotechnology: General

  • Effects of Physician-Directed Pharmaceutical Promotion on Prescription Behaviors: Longitudinal Evidence (NBER)
  • Pharmacyclics/Janssen Offer Suite Of Patient Support Programs For Imbruvica (Pink Sheet-$)
  • Addiction Specialists Wary of New Painkiller (NYTimes)
  • Orphan Drug Economics: What's The Right Price For Rare Disease Drugs? (RPM Report-$)

US: Medical Devices

  • Shuren To Lawmakers: Sequestration Is "Killing Us" (Gray Sheet-$)
  • Lawmakers increase pressure on device maintenance standards (The Hill)
  • IMS Health Suggests All Mobile Medical Apps Be Subject To Clinical Trials (IHP-$)
  • AdvaMed Statement on House FDASIA Hearing (Advamed)
  • Salix Announces Approval of Additional Injection Techniques for Deflux (Press)
  • Lumenis wins U.S. & Japanese clearance for retinal laser treatment (Mass Device)

US: Dietary Supplements

  • Supplement Firms Confounded By Identity Testing Waiver Process (Tan Sheet-$)
  • So Many Supplements, So Little Regulation (Newsweek)

US: Assorted And Government

  • FDA: The Differences with Pharmaceutical and Device Promotion Standards (Policy and Medicine)
  • Wise Budgeting: "A Deadly Serious Challenge for Policymakers" (Strengthen FDA)
  • Third of NHLBI-funded trials never see timely publication (Cardiovascular Business)
  • Trade deals threatened by Hill opposition (The Hill)
  • Congress passes bill for pediatric research (The Hill)

Upcoming Meetings And Events

  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • French court rules TÜV liable in PIP breast implants trial (DW) (EP Vantage)
  • MHRA: Epilepsy Drugs Should not be Substituted (Financial Times-$)
  • German Pharma Balks As Second HTA Retrospective Assessment Includes Orphan Drugs (Pink Sheet-$)
  • EU notified body joint assessments: beneficial, but where are the shortfalls? (Clinica-$)
  • EMA encourages companies to submit quality type-I variations for 2013 by end of November (EMA)
  • EMA Revamp Could Be Hampered By Tight Budget And Staffing (Tan Sheet-$)
  • European Commission Approves Gilead's Vitekta, an Integrase Inhibitor for the Treatment of HIV-1 Infection (Press)
  • European Parliament Finally Closes Books on EMA's 2011 Budget (EP) (EP)
  • Pfizer breaks off German pricing talks, withdraws Bosulif (BioCentury)
  • UK expert group calls for earlier patient access to medicines (Pharma Letter-$) (Pharma Times)
  • European Parliament Proposes New User Fee Rates for Pharmcovigilance Activities (EP)
  • Commission launches new research projects to fight drug-resistant bacteria (EurActiv) (Reuters) (Pharma Letter-$) (EC) (EC)
  • IQWiG rebuffs Roche's Erivedge (BIoCentury)
  • Report looks at impact of new law governing clinical trials in Switzerland (Pharma Letter-$)
  • EU approval for Bayer's prostate cancer drug (PMLive) (Pharma Times) (BioCentury)
  • Bruin Biometrics Gets CE Mark for Handheld SEM Scanner to Detect Pressure Ulcers (MedGadget)

Asia

  • Novo Nordisk hemophilia drug moves closer to approval in Japan (Reuters)
  • Japanese team tightening Ranbaxy unit operations (Business Standard)
  • Indian Govt to change D&C Rules on labelling norms, shelf life of medical devices (PharmaBiz)
  • Indian Health Ministry to consult Commerce, Pharma depts on continued permitting of BA/BE studies for export purpose (PharmaBiz)
  • GlaxoSmithKline's CEO Andrew Witty backs India's pharma policy, cautious on acquisitions (India Times)
  • Vaccination scandal taints reputation of India drug trials (Financial Times-$)

Other International

  • Health Canada to Increase Transparency Around Medical Device Trials (Health Canada)
  • Kenya drug regulatory authority automates licensing processes to boost trade (Pharma Africa-$)

General Regulatory And Interesting Articles

  • Physician oversight and recruitment issues in biosimilar trials, CROs say (Biopharma Reporter)
  • Gut Bacteria Might Guide The Workings Of Our Minds (NPR)
  • Surgeons to give man 3-D printed face (MedCity News)

Regulatory Reconnaissance #204 - 18 November 2013

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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